MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Insufficient Information (4580)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi for left knee.It was reported through stryker facebook page: i love my stryker components.But after having ecoli in my right leg in my bone marrow, i ended up with a competitor component and i hate it.It shifted in pt on a recumbent bike & caused my left knee to pop like a cork out of a wine bottle.Since it's a chromium colbalt metal, it's not mri or ct compatible.Dr.Who replaced my right one doesn't want to find what shifted nor find what popped in my left in one.Right hip replacement also has a stryker component in it.Also have a torn glutaeus medius muscle in the right hip.Fb comment received, 1-mar-2024: fb comment received, stay away from competitor.That was my first knee replacement component for 6 years and 10 & 1/2 months.I had that junk taken out on (b)(6) 2005.Best component ever.Had my right knee replaced (b)(6) 2005 with the same component no problems, right hip has a stryker component in it done on (b)(6) 2009.Right knee now has a crappy competitor because of ecoli was in my bone marrow from being in a filthy, nasty, smelly rehab center after i broke my right femur just above my right knee replacement.

Manufacturer Narrative

An event regarding issue unclear involving an unknown knee was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the patient reported that noise coming from the knee.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi for left knee.It was reported through stryker facebook page: i love my stryker components.But after having ecoli in my right leg in my bone marrow, i ended up with a competitor component and i hate it.It shifted in pt on a recumbent bike & caused my left knee to pop like a cork out of a wine bottle.Since it's a chromium colbalt metal, it's not mri or ct compatible.Dr.Who replaced my right one doesn't want to find what shifted nor find what popped in my left in one.Right hip replacement also has a stryker component in it.Also have a torn glutenus medius muscle in the right hip.Fb comment received, 1-mar-2024: fb comment received, stay away from competitor.That was my first knee replacement component for 6 years and 10 & 1/2 months.I had that junk taken out on (b)(6) 2005.Best component ever.Had my right knee replaced (b)(6) 2005 with the same component no problems, right hip has a stryker component in it done on (b)(6) 2009.Right knee now has a crappy competitor because of ecoli was in my bone marrow from being in a filthy, nasty, smelly rehab center after i broke my right femur just above my right knee replacement.Additional fb comment received: "i was 39 when i had my first knee replacement.The dr.Deliberately intentionally and purposely messed mine up.He died 5 months & 9 days later of a massive heart attack.".

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18891671
• MDR Text Key: 337509480
• Report Number: 0002249697-2024-00391
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female